Evaluation of the diagnostic accuracy of Xpert® Mpox and STANDARD™ M10 MPX/OPX for the detection of monkeypox virus

Alessandra Romero Ramirez; Anushri Somasundaran; Nadia Kontogianni; Jacob Parkes; Yusra Hussain; Susie Gould; Chris Williams; Dom Wooding; Richard Body; Hayley E. Hardwick; J. Kenneth Baillie; Jake Dunning; Malcolm G. Semple; Tom Fletcher; Thomas Edwards; Devy Emperador; Ana I. Cubas-Atienzar

doi:10.1016/j.jinf.2025.106413

Evaluation of the diagnostic accuracy of Xpert® Mpox and STANDARD™ M10 MPX/OPX for the detection of monkeypox virus

Alessandra Romero Ramirez
, Anushri Somasundaran
, Nadia Kontogianni
, Jacob Parkes
, Yusra Hussain
, Susie Gould
, Chris Williams
, Dom Wooding
, Richard Body
, Hayley E. Hardwick
, J. Kenneth Baillie
, Jake Dunning
, Malcolm G. Semple
, Tom Fletcher
, Thomas Edwards
, Devy Emperador
, Ana I. Cubas-Atienzar

Research output: Contribution to journal › Article › peer-review

3 Citations (Scopus)

Abstract

Objectives

Evaluation of diagnostic accuracy of two point-of-care (POC) molecular diagnostic tests for the detection of monkeypox virus (MPXV): Xpert® Mpox (Cepheid, Inc., USA) and STANDARD™ M10 MPX/OPX (SD Biosensor, Inc., Korea).

Methods

Diagnostic accuracy of both POC platforms was evaluated using 53 upper-respiratory swabs (URS) and 32 skin lesions swabs (SS) collected from mpox and COVID-19 patients in the UK against the Sansure (Sansure Biotech Inc.) and CDC reference qPCR tests. The analytical sensitivity of both platforms was assessed using a viral isolate from II, B.1 lineage.

Results

The overall sensitivity and specificity of the Xpert® Mpox was 97.67% [95% CI 87.71–99.94%] and 88.57% [95% CI 73.26–96.80%] and 97.44% [95% CI 86.52–99.94%] and 74.42% [95% CI 58.83–86.48%] comparing the Sansure and CDC qPCR, respectively and for the M10 MPX/OPX was 87.80% [95% CI 73.80–95.92%] and 76.60% [95% CI 61.97–87.70%] and 94.29% [95% CI 80.84–99.30%] and 86.67% [95% CI 73.21–94.95%] with the Sansure and CDC qPCR.

Conclusion

The Xpert® Mpox had good diagnostic accuracy for both sample types while the M10 MPX/OPX clinical accuracy was deficient with URS. Our data supports the use of URS during the first 3 days of symptoms onset for mpox diagnosis.

Original language	English
Article number	106413
Pages (from-to)	106413
Journal	Journal of Infection
Volume	90
Issue number	2
DOIs	https://doi.org/10.1016/j.jinf.2025.106413
Publication status	Published - 14 Jan 2025

Keywords

Diagnostics
Monkeypox
Mpox
MPXV
Orthopoxvirus
PCR
Point-of-care (POC)

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Cite this

Romero Ramirez, A., Somasundaran, A., Kontogianni, N., Parkes, J., Hussain, Y., Gould, S., Williams, C., Wooding, D., Body, R., Hardwick, H. E., Baillie, J. K., Dunning, J., Semple, M. G., Fletcher, T., Edwards, T., Emperador, D., & Cubas-Atienzar, A. I. (2025). Evaluation of the diagnostic accuracy of Xpert® Mpox and STANDARD™ M10 MPX/OPX for the detection of monkeypox virus. Journal of Infection, 90(2), 106413. Article 106413. https://doi.org/10.1016/j.jinf.2025.106413

@article{8540d36506994ea6b610a350a644954e,

title = "Evaluation of the diagnostic accuracy of Xpert{\textregistered} Mpox and STANDARD{\texttrademark} M10 MPX/OPX for the detection of monkeypox virus",

abstract = "ObjectivesEvaluation of diagnostic accuracy of two point-of-care (POC) molecular diagnostic tests for the detection of monkeypox virus (MPXV): Xpert{\textregistered} Mpox (Cepheid, Inc., USA) and STANDARD{\texttrademark} M10 MPX/OPX (SD Biosensor, Inc., Korea).MethodsDiagnostic accuracy of both POC platforms was evaluated using 53 upper-respiratory swabs (URS) and 32 skin lesions swabs (SS) collected from mpox and COVID-19 patients in the UK against the Sansure (Sansure Biotech Inc.) and CDC reference qPCR tests. The analytical sensitivity of both platforms was assessed using a viral isolate from II, B.1 lineage.ResultsThe overall sensitivity and specificity of the Xpert{\textregistered} Mpox was 97.67\% [95\% CI 87.71–99.94\%] and 88.57\% [95\% CI 73.26–96.80\%] and 97.44\% [95\% CI 86.52–99.94\%] and 74.42\% [95\% CI 58.83–86.48\%] comparing the Sansure and CDC qPCR, respectively and for the M10 MPX/OPX was 87.80\% [95\% CI 73.80–95.92\%] and 76.60\% [95\% CI 61.97–87.70\%] and 94.29\% [95\% CI 80.84–99.30\%] and 86.67\% [95\% CI 73.21–94.95\%] with the Sansure and CDC qPCR.ConclusionThe Xpert{\textregistered} Mpox had good diagnostic accuracy for both sample types while the M10 MPX/OPX clinical accuracy was deficient with URS. Our data supports the use of URS during the first 3 days of symptoms onset for mpox diagnosis.",

keywords = "Diagnostics, Monkeypox, Mpox, MPXV, Orthopoxvirus, PCR, Point-of-care (POC)",

author = "\{Romero Ramirez\}, Alessandra and Anushri Somasundaran and Nadia Kontogianni and Jacob Parkes and Yusra Hussain and Susie Gould and Chris Williams and Dom Wooding and Richard Body and Hardwick, \{Hayley E.\} and Baillie, \{J. Kenneth\} and Jake Dunning and Semple, \{Malcolm G.\} and Tom Fletcher and Thomas Edwards and Devy Emperador and Cubas-Atienzar, \{Ana I.\}",

year = "2025",

month = jan,

day = "14",

doi = "10.1016/j.jinf.2025.106413",

language = "English",

volume = "90",

pages = "106413",

journal = "Journal of Infection",

issn = "0163-4453",

publisher = "W.B. Saunders Ltd",

number = "2",

}

Romero Ramirez, A, Somasundaran, A , Kontogianni, N, Parkes, J, Hussain, Y, Gould, S , Williams, C , Wooding, D, Body, R, Hardwick, HE, Baillie, JK, Dunning, J, Semple, MG, Fletcher, T , Edwards, T, Emperador, D & Cubas-Atienzar, AI 2025, 'Evaluation of the diagnostic accuracy of Xpert® Mpox and STANDARD™ M10 MPX/OPX for the detection of monkeypox virus', Journal of Infection, vol. 90, no. 2, 106413, pp. 106413. https://doi.org/10.1016/j.jinf.2025.106413

TY - JOUR

T1 - Evaluation of the diagnostic accuracy of Xpert® Mpox and STANDARD™ M10 MPX/OPX for the detection of monkeypox virus

AU - Romero Ramirez, Alessandra

AU - Somasundaran, Anushri

AU - Kontogianni, Nadia

AU - Parkes, Jacob

AU - Hussain, Yusra

AU - Gould, Susie

AU - Williams, Chris

AU - Wooding, Dom

AU - Body, Richard

AU - Hardwick, Hayley E.

AU - Baillie, J. Kenneth

AU - Dunning, Jake

AU - Semple, Malcolm G.

AU - Fletcher, Tom

AU - Edwards, Thomas

AU - Emperador, Devy

AU - Cubas-Atienzar, Ana I.

PY - 2025/1/14

Y1 - 2025/1/14

N2 - ObjectivesEvaluation of diagnostic accuracy of two point-of-care (POC) molecular diagnostic tests for the detection of monkeypox virus (MPXV): Xpert® Mpox (Cepheid, Inc., USA) and STANDARD™ M10 MPX/OPX (SD Biosensor, Inc., Korea).MethodsDiagnostic accuracy of both POC platforms was evaluated using 53 upper-respiratory swabs (URS) and 32 skin lesions swabs (SS) collected from mpox and COVID-19 patients in the UK against the Sansure (Sansure Biotech Inc.) and CDC reference qPCR tests. The analytical sensitivity of both platforms was assessed using a viral isolate from II, B.1 lineage.ResultsThe overall sensitivity and specificity of the Xpert® Mpox was 97.67% [95% CI 87.71–99.94%] and 88.57% [95% CI 73.26–96.80%] and 97.44% [95% CI 86.52–99.94%] and 74.42% [95% CI 58.83–86.48%] comparing the Sansure and CDC qPCR, respectively and for the M10 MPX/OPX was 87.80% [95% CI 73.80–95.92%] and 76.60% [95% CI 61.97–87.70%] and 94.29% [95% CI 80.84–99.30%] and 86.67% [95% CI 73.21–94.95%] with the Sansure and CDC qPCR.ConclusionThe Xpert® Mpox had good diagnostic accuracy for both sample types while the M10 MPX/OPX clinical accuracy was deficient with URS. Our data supports the use of URS during the first 3 days of symptoms onset for mpox diagnosis.

AB - ObjectivesEvaluation of diagnostic accuracy of two point-of-care (POC) molecular diagnostic tests for the detection of monkeypox virus (MPXV): Xpert® Mpox (Cepheid, Inc., USA) and STANDARD™ M10 MPX/OPX (SD Biosensor, Inc., Korea).MethodsDiagnostic accuracy of both POC platforms was evaluated using 53 upper-respiratory swabs (URS) and 32 skin lesions swabs (SS) collected from mpox and COVID-19 patients in the UK against the Sansure (Sansure Biotech Inc.) and CDC reference qPCR tests. The analytical sensitivity of both platforms was assessed using a viral isolate from II, B.1 lineage.ResultsThe overall sensitivity and specificity of the Xpert® Mpox was 97.67% [95% CI 87.71–99.94%] and 88.57% [95% CI 73.26–96.80%] and 97.44% [95% CI 86.52–99.94%] and 74.42% [95% CI 58.83–86.48%] comparing the Sansure and CDC qPCR, respectively and for the M10 MPX/OPX was 87.80% [95% CI 73.80–95.92%] and 76.60% [95% CI 61.97–87.70%] and 94.29% [95% CI 80.84–99.30%] and 86.67% [95% CI 73.21–94.95%] with the Sansure and CDC qPCR.ConclusionThe Xpert® Mpox had good diagnostic accuracy for both sample types while the M10 MPX/OPX clinical accuracy was deficient with URS. Our data supports the use of URS during the first 3 days of symptoms onset for mpox diagnosis.

KW - Diagnostics

KW - Monkeypox

KW - Mpox

KW - MPXV

KW - Orthopoxvirus

KW - PCR

KW - Point-of-care (POC)

U2 - 10.1016/j.jinf.2025.106413

DO - 10.1016/j.jinf.2025.106413

M3 - Article

SN - 0163-4453

VL - 90

SP - 106413

JO - Journal of Infection

JF - Journal of Infection

IS - 2

M1 - 106413

ER -

Evaluation of the diagnostic accuracy of Xpert® Mpox and STANDARD™ M10 MPX/OPX for the detection of monkeypox virus

Abstract

Keywords

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